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Evaluation Of Celecoxib In Combination With Weekly Docetaxel In Elderly (70 Years) Or Poor Performance Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

Phase 2
18 Years
Not Enrolling
Lung Cancer

Thank you

Trial Information

Evaluation Of Celecoxib In Combination With Weekly Docetaxel In Elderly (70 Years) Or Poor Performance Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)


- Determine the efficacy and feasibility of celecoxib combined with docetaxel as
first-line therapy in elderly or poor performance status patients with advanced
non-small cell lung cancer.

- Determine the response rate of patients treated with this regimen.

- Determine the toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral celecoxib twice daily (beginning on day -7 of the first course) and
docetaxel IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days in the
absence of disease progression or unacceptable toxicity. Patients who achieve a complete
response (CR) receive 2 additional courses after CR. Patients who achieve stable disease
(SD) or a partial response (PR) receive a minimum of 2 additional courses after SD or PR. At
the discretion of the treating physician, patients then receive maintenance therapy
comprising celecoxib only.

Patients who discontinue therapy for disease progression or unacceptable toxicity are
followed for at least 6 months.

PROJECTED ACCRUAL: A total of 21-39 patients will be accrued for this study within 13-28

Inclusion Criteria


- Diagnosis of non-small cell lung cancer (NSCLC)

- Stage IIIB with pleural effusion or stage IV disease

- Age 70 years and over with SWOG performance status 0-2 OR age 18 to 69 with SWOG
performance status 2

- Measurable or evaluable disease

- No symptomatic or untreated brain or leptomeningeal metastases

- Previously treated patients must be neurologically stable for 4 weeks after
completion of appropriate therapy



- See Disease Characteristics

- 18 and over

Performance status:

- See Disease Characteristics

- SWOG 0-2

Life expectancy:

- Not specified


- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

- Hemoglobin at least 8 g/dL


- Bilirubin no greater than upper limit of normal (ULN)

- AST/ALT no greater than ULN (or no greater than 2.5 times ULN if alkaline phosphatase
no greater than ULN)

- Alkaline phosphatase no greater than ULN (or no greater than 5 times ULN if AST/ALT
no greater than ULN)

- No history of chronic hepatitis


- Creatinine no greater than 1.5 times ULN


- No uncontrolled congestive heart failure

- No uncontrolled angina

- No myocardial infarction and/or stroke within the past 6 months

- No active thromboembolic event within the past 4 weeks


- No gastrointestinal bleeding within the past 6 months

- No history of peptic ulcer disease


- No prior hypersensitivity reaction to docetaxel or other drugs formulated with
polysorbate 80

- No prior allergy to any non-steroidal anti-inflammatory drug

- No other prior or concurrent malignancy within the past 3 years except adequately
treated squamous cell or basal cell skin cancer or carcinoma in situ of the cervix

- No grade 2 or greater peripheral neuropathy

- No other serious concurrent medical illness

- No history of dementia, active psychiatric disorder, or other condition that would
interfere with ability to take oral medication or preclude compliance with study

- HIV negative

- Must weigh at least 50 kg (110 pounds)

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective barrier contraception


Biologic therapy:

- No prior biologic therapy for NSCLC


- No prior chemotherapy for NSCLC

Endocrine therapy:

- At least 3 days since prior steroids


- At least 4 weeks since prior radiotherapy

- No prior radiotherapy to target lesion


- At least 4 weeks since prior major surgery


- Prior intermittent use of non-steroidal anti-inflammatory drugs (NSAIDs), including
rofecoxib or celecoxib, allowed

- At least 1 week since prior fluconazole

- No recent prior NSAIDs, including rofecoxib or celecoxib, for a duration of more than
30 consecutive days

- No concurrent fluconazole or lithium

- No concurrent NSAIDs except aspirin administered at a dose of no more than 325 mg/day
for cardiovascular conditions

- No other concurrent cyclo-oxygenase-2 inhibitors

- No other concurrent investigational agents

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Efficacy of combining celecoxib with docetaxel in elderly (> or = 70 yrs old) or poor performance status (PS)of 2

Outcome Description:

Blood levels of VEGF & PGE2

Outcome Time Frame:

Weeks 1, 2, and 3

Safety Issue:


Principal Investigator

Shirish M. Gadgeel, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Barbara Ann Karmanos Cancer Institute


United States: Federal Government

Study ID:




Start Date:

October 2001

Completion Date:

April 2009

Related Keywords:

  • Lung Cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Barbara Ann Karmanos Cancer Institute Detroit, Michigan  48201